Jämför utfall för stomavänderingssår mellan NPWT och läkning genom sekundär intention
Negativ trycksårbehandling jämfört med läkning genom sekundär intention vid stomåtervändning: En randomiserad kontrollerad studie som utvärderar kirurgiska sårinfektioner och sårutfall
This was a single-center, parallel-group randomized controlled trial conducted in 2025 at the General Surgery Ward of the Sindh Institute of Urology and Transplantation (SIUT), Karachi. The study compared negative pressure wound therapy (NPWT) with healing by secondary intention (SIH) for patients undergoing stoma reversal surgery.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Study Design and Participants A total of 92 adult patients (aged ≥18 years) scheduled for stoma reversal were assessed for eligibility. Of these, 72 patients who met the inclusion criteria and provided informed consent were enrolled and randomized in a 1:1 ratio into NPWT (intervention) and SIH (control) groups (n=36 each). Eligibility criteria included patients undergoing elective or emergency stoma reversal with conventional layered closure of the muscular layer and skin management by either NPWT or SIH. Exclusion criteria included use of skin closure techniques other than suture, prolonged antibiotic use before surgery, or need for reoperation for causes other than surgical site infection (SSI).
Randomization and Allocation Random allocation was performed using simple random sampling by lot draw. A list of consecutive serial numbers with equal halves of even and odd numbers was utilized. Each number was printed separately on slips of paper and folded to conceal. A slip was drawn for each patients allocation. Patients who drew odd-numbered lots were assigned to the treatment group (NPWT), and those with even-numbered lots to the control group (SIH). This approach ensured unbiased allocation while maintaining transparency.
Interventions In both groups, stoma reversal was performed following standard operative protocols with fascial layer closure using absorbable sutures. In the NPWT group, after the procedure, the skin was left open and covered with four sterile gauze layers. An 18 Fr Nelaton catheter was placed directly over the wound and sealed with transparent, waterproof adhesive to create a vacuum. Continuous negative pressure was applied at 15 mmHg. Dressings were evaluated for SSI on postoperative days 2 and 4 using the ASEPSIS score; if no infection was present, the NPWT dressing was reapplied. On postoperative day 6, a final wound assessment was conducted, and further management was carried out as per departmental protocol.
In the SIH group, the wound was left open and dressed using four layers of sterile gauze and a transparent adhesive dressing. Similar to the NPWT group, dressing changes and assessments using the ASEPSIS score were performed on postoperative days 2, 4, and 6. If an infection was identified, standard management protocols were followed.
All patients received prophylactic antibiotics with piperacillin-tazobactam (4.5 g) administered 30 minutes before incision and three postoperative doses of the same antibiotic.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Sindh
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Karachi, Sindh, Pakistan, 74200
- Sindh Institute of Urology and Transplantation
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
All patients aged between 18-80 years undergoing stoma reversal surgery were included, following their formal consent for inclusion in the study protocol.
Exclusion Criteria:
- Patients with history of prolonged antibiotic use prior to stoma reversal surgery (>1months).
- Patients with prior skin condition that required medical treatment (for instance, Plaque Psoriasis).
- Patient with prior history of wound-related complication (like keloids or hypertrophic scars).
Furthermore, after allocation, the patients with the following protocol violations were also excluded:
- Patients who had undergone any other forms of wound closure after stoma reversal, that deviated from the study protocol.
- Patients who were re-operated during the hospital stay for any other reason than surgical site infection.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Negative pressure wound therapy
In the NPWT (negative-pressure wound therapy) group, after the procedure, the skin was left open and covered with four sterile gauze layers. An 18 Fr Nelaton catheter was placed directly over the wound and sealed with transparent, waterproof adhesive to create a vacuum. Continuous negative pressure was applied at 15 mmHg. Dressings were evaluated for Surgical site infection on postoperative days 2 and 4 using the ASEPSIS score; if no infection was present, a NPWT dressing was reapplied. On postoperative day 6, a final wound assessment was conducted, and further management was carried out as per departmental protocol. |
In the NPWT (negative pressure wound therapy) group, after the procedure, the skin was left open and covered with four sterile gauze layers. An 18 Fr Nelaton catheter was placed directly over the wound and sealed with transparent, waterproof adhesive to create a vacuum. Continuous negative pressure was applied at 15 mmHg. Dressings were evaluated for SSI on postoperative days 2 and 4 using the ASEPSIS score; if no infection was present, NPWT dressing was reapplied. On postoperative day 6, final wound assessment was conducted and further management was carried out as per departmental protocol. |
|
Inget ingripande: secondary intention healing
In the SIH (secondary intention healing) group, the wound was left open and dressed using four layers of sterile gauze and a transparent adhesive dressing. Similar to the NPWT group, dressing changes and assessments using the ASEPSIS score were performed on postoperative days 2, 4, and 6. If an infection was identified, standard management protocols were followed. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Highest Postoperative Asepsis Score for SSI assessment
Tidsram: Post-operative day (POD) 2, 4 and 6 (ASEPSIS score recorded)
|
The primary outcome was the occurrence and severity of surgical site infection, assessed using the ASEPSIS scoring system (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay duration as an inpatient) on postoperative days 2, 4, and 6. The highest ASEPSIS score recorded across these time points was used for between-group comparison. The score may vary between. 0-70 with higher score representing worse outcome. |
Post-operative day (POD) 2, 4 and 6 (ASEPSIS score recorded)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Scar Cosmesis Assessment and Rating (SCAR) score on postoperative day 30
Tidsram: On Postoperative day 30 wound cosmesis were assessed using scar scale
|
All patient's operative wounds were assessed for cosmesis on postoperative day 30. This was performed utilizing the Scar Cosmesis Assessment and Rating (SCAR) scale for objective assessment. Scores range from 0 (best possible scar) to 15 (worst possible scar). |
On Postoperative day 30 wound cosmesis were assessed using scar scale
|
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Length of Stay
Tidsram: 6-12 days. Following completion of study observations on postoperative day 6, patient may be discharged on meeting the discharge criteria. Expected between 6-12 days.
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Duration of stay assessed as: number of days of hospital stay after the index procedure till the patient discharged from hospital was recorded. |
6-12 days. Following completion of study observations on postoperative day 6, patient may be discharged on meeting the discharge criteria. Expected between 6-12 days.
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SIUT-ERC-2025/A-275
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